Job Title: Manufacturing Executive – Reagent Manufacturing Location: Bangalore Company: Our Client (A leading MedTech company designing and manufacturing automated medical devices for precision diagnostics) Company Overview Our client is committed to innovation, quality, and regulatory compliance in the development of cutting-edge automated medical devices for precision diagnostics. They are currently seeking a motivated Manufacturing Executive – Reagent Manufacturing to join their team in Bangalore. Key Responsibilities Prepare buffers and solutions following pre-approved SOPs and batch production records. Measure and weigh chemicals accurately using calibrated instruments. Formulate and prepare reagents in line with standardized procedures and specifications. Perform buffer filtration, monitor pH levels, and ensure batch compliance. Support investigations and deviations related to buffer preparation. Operate in a classified cleanroom using aseptic techniques and proper gowning. Maintain workspace cleanliness adhering to GMP, GLP, and ISO standards. Perform cleanroom operations including machine setup, in-process inspection, filling, and packaging. Follow gowning/de-gowning protocols to prevent contamination. Handle materials and finished goods within the cleanroom per SOPs. Conduct in-process quality checks to ensure compliance and product standards. Identify and resolve issues during the manufacturing process (e.g., equipment faults, deviations). Perform routine equipment cleaning and maintenance. Complete batch records, logs, and inspection reports accurately. Contribute to process improvement and participate in problem-solving initiatives. Ensure compliance with GMP, GDP, and ISO regulatory guidelines. Cleanroom Awareness and Knowledge Requirements Understanding of cleanroom classifications and standards. Adherence to sterile gowning and aseptic techniques. Awareness of contamination risks and prevention strategies. Familiarity with chemical handling, labeling, and disposal in cleanroom environments. Cleanroom behavior awareness: minimal movement, controlled interactions, and approved workflow adherence. Entry/exit procedure compliance including airlock systems and gowning. Knowledge of environmental monitoring and in-process quality check execution. Commitment to high product hygiene and safety standards. Understanding the impact of hygiene on product integrity and customer trust. Qualifications Bachelor’s degree in Biotechnology, Biochemistry, or a related field. 2–3 years of relevant experience in IVD or related sectors. Mandatory experience in buffer preparation and cleanroom operations. Familiarity with automated filling machinery. Prior experience in the medical device industry is preferred. Strong understanding of cleanroom protocols and GMP compliance. Physical Requirements Ability to stand for long durations, lift heavy items, and perform repetitive tasks. Languages Required Kannada English Show more Show less